FILM COATED TABLETS (divisible): 20 x 100 mg.
Should be initiated by a physician experienced in the treatment of patients with CML or GIST, respectively.
Should be administered orally, with a meal and a large glass of water. The tablets may be dispersed in a glass of water or apple juice, and then administered immediately after complete disintegration of the tablets.
Doses of 400 mg or 600 mg should be administered once daily. Daily doses of 800 mg should be administered in 2 divided doses, in the morning and in the evening.
CML: 400 mg daily for patients in chronic phase CML and 600 mg daily for patients in accelerated phase or blast crisis. Treatment should be continued as long as the patient continues to benefit. Dose increase from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg daily in patients in accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukemia-related neutropenia or thrombocytopenia.
Children: 260 mg/m2 and 340 mg/m2 daily for children with chronic phase CML and advanced phases CML, respectively. Total daily dose should not exceed adult equivalent doses of 400 mg and 600 mg, respectively. Treatment can be given as a once daily dose or in two divided doses, in the morning and in the evening. See prescribing information for full details.
GIST: 400 mg daily for patients with unresectable and/or metastatic, malignant GIST. A dose increase from 400 mg to 600 or 800 mg for patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy. Treatment should be continued until disease progression. Prescribing Restrictions: